Duramed Pharmaceuticals, Bala Cynwyd, PA, Jan. 6 (DDMAC).Division of Drug Marketing, Advertising, and Communications (DDMAC DDMAC Division of Drug Marketing, Advertising and Communications ) reviewed a professional journal advertisement for Duramed's Cenestin (synthetic conjugated estrogens Estrogens Hormones produced by the ovaries, the female sex glands. Mentioned in: Acne, Polycystic Ovary Syndrome estrogens (es´trōjenz), n. , A) Tablets and determined the ad to be misleading because it omitted material risk information, minimized risks associated with Cenestin therapy, and presented unsubstantiated implied superiority claims. FDA-approved product labeling (PI) for Cenestin contains numerous important contraindications, warnings, precautions and adverse events (AEs). Most importantly, the labeling contains a Boxed Warning that states estrogens increase the risk of endometrial cancer. Other risks in the PI, but not mentioned in the ad, included reports of increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli emboli /em·bo·li/ (em´bo-li) plural of embolus. Emboli Plural of embolus. An embolus is something that blocks the blood flow in a blood vessel. and deep vein thrombosis A blood clot (thrombos) in a vein deep within the muscle, typically in the thigh or calf. It is caused by disease or the lack of activity such as sitting for hours at a computer screen. in postmenopausal women (50 to 79 years of age); and an increased risk of developing probable dementia in postmenopausal women 65 years of age or older. Furthermore, the ad also suggested that Cenestin was superior to other estrogen formulations (patch or tablet)--a claim that has not been demonstrated by substantial evidence or substantial clinical experience. F-B F-B Forward - Backward (radar image analysis) ; Doc. 13708W |
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